Safety of dabigatran etexilate for the secondary prevention of venous thromboembolism in children

Autoři	BRANDAO L. R. ALBISETTI M. HALTON J. BOMGAARS L. CHALMERS E. MITCHELL L. G. NURMEEV I. SVIRIN P. KUHN Tomáš ZAPLETAL Ondřej TARTAKOVSKY I. SIMETZBERGER M. HUANG F. L. SUN Z. C. KREUZER J. GROPPER S. BRUECKMANN M. LUCIANI M.
Rok publikování	2020
Druh	Článek v odborném periodiku
Časopis / Zdroj	Blood
Fakulta / Pracoviště MU	Lékařská fakulta
Citace
www	https://watermark.silverchair.com/bloodbld2019000998.pdf?token=AQECAHi208BE49Ooan9kkhW_Ercy7Dm3ZL_9Cf3qfKAc485ysgAAA-cwggPjBgkqhkiG9w0BBwagggPUMIID0AIBADCCA8kGCSqGSIb3DQEHATAeBglghkgBZQMEAS4wEQQMw-3e0CJJawRicbJVAgEQgIIDmsR14TKvPR0YxTM32ezJHDLRAtNrsy-0VtZ
Doi	http://dx.doi.org/10.1182/blood.2019000998
Klíčová slova	DEEP-VEIN THROMBOSIS; RISK THROMBOPHILIA STATUS; POSTTHROMBOTIC SYNDROME; CLINICAL-TRIALS; ANTITHROMBOTIC THERAPY; MULTICENTER; WARFARIN; PHARMACOKINETICS; EFFICACY; VTE
Popis	This open-label, single-arm, prospective cohort trial is the first phase 3 safety study to describe outcomes in children treated with dabigatran etexilate for secondary venous thromboembolism (VTE) prevention. Eligible children aged 12 to <18 years (age stratum 1), 2 to <12 years (stratum 2), and >3 months to <2 years (stratum 3) had an objectively confirmed diagnosis of VTE treated with standard of care (SOC) for >= 3 months, or had completed dabigatran or SOC treatment in the DIVERSITY trial (NCT01895777) and had an unresolved clinical thrombosis risk factor requiring further anticoagulation. Children received dabigatran for up to 12 months, or less if the identified VTE clinical risk factor resolved. Primary end points included VTE recurrence, bleeding events, and mortality at 6 and 12 months. Overall, 203 children received dabigatran, with median exposure being 36.3 weeks (range, 0-57 weeks); 171 of 203 (84.2%) and 32 of 203 (15.8%) took capsules and pellets, respectively. Overall, 2 of 203 children (1.0%) experienced on-treatment VTE recurrence, and 3 of 203 (1.5%) experienced major bleeding events, with 2 (1.0%) reporting clinically relevant nonmajor bleeding events, and 37 (18.2%) minor bleeding events. There were no on-treatment deaths. On-treatment postthrombotic syndrome was reported for 2 of 162 children (1.2%) who had deep vein thrombosis or central-line thrombosis as their most recent VTE. Pharmacokinetic/pharmacodynamic relationships of dabigatran were similar to those in adult VTE patients. In summary, dabigatran showed a favorable safety profile for secondary VTE prevention in children aged from >3 months to <18 years with persistent VTE risk factor(s).